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Den fjerde venstre atrielle appendage okklusionsundersøgelse (LAAOS-4)

15. september 2026 opdateret af: Hamilton Health Sciences Corporation

Den fjerde venstre atrielle appendage okklusionsundersøgelse (LAAOS-4)

LAAOS-4 aims to determine if catheter-based endovascular left atrial appendage occlusion prevents ischemic stroke or systemic embolism in participants with atrial fibrillation, who remain at high risk of stroke, despite receiving ongoing treatment with oral anticoagulation.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Enhed: WATCHMAN device

Detaljeret beskrivelse

LAAOS-4 is a multicentre, prospective, open-label, randomized controlled trial with blinded assessment of endpoints (PROBE) to determine if catheter-based endovascular left atrial appendage occlusion prevents ischemic stroke or systemic embolism in participants with atrial fibrillation, who remain at high risk of stroke, despite receiving ongoing treatment with oral anticoagulation.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

4000

Fase

Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Navn: Program Director
Telefonnummer: 905-521-2100
E-mail: LAAOS-4@phri.ca

Studiesteder

Belgien
- - Brussels, Belgien, 1090
    - Rekruttering
    - Universitair Ziekenhuis Brussel
    - Ledende efterforsker:
      
      Stijn Lochy, MD
  - Liège, Belgien, 4000
    - Rekruttering
    - CHR de la Citadelle
    - Ledende efterforsker:
      
      Jean-Manuel Herzet, MD
- Antwerpen
  - Bonheiden, Antwerpen, Belgien, 2820
    - Rekruttering
    - Imeldaziekenhuis
    - Ledende efterforsker:
      
      Philippe Debruyne, MD
- East-Flanders
  - Aalst, East-Flanders, Belgien, 9300
    - Rekruttering
    - AZORG vzw and Hartcentrum Aalst
    - Ledende efterforsker:
      
      Tom De Potter, MD
- Hainaut
  - La Louvière, Hainaut, Belgien, 7100
    - Rekruttering
    - ASBL CHU Helora - Hôpital de La Louvière - site Jolimont
    - Ledende efterforsker:
      
      Antoine de Meester, MD
- Oost-Vlaanderen
  - Ronse, Oost-Vlaanderen, Belgien, 9600
    - Rekruttering
    - AZ Glorieux
    - Ledende efterforsker:
      
      Becker Alzand, MD
- West-Vlaanderen
  - Bruges, West-Vlaanderen, Belgien, 8000
    - Rekruttering
    - AZ Sint Jan Brugge AV
    - Ledende efterforsker:
      
      Ian Buysschaert, MD
  - Roeselare, West-Vlaanderen, Belgien, 8800
    - Rekruttering
    - AZ Delta VZW
    - Ledende efterforsker:
      
      Maarten Vanhaverbeke, MD
Canada
- Alberta
  - Calgary, Alberta, Canada, T2N 1N4
    - Rekruttering
    - University of Calgary
    - Ledende efterforsker:
      
      Stephen Wilton, MD
- British Columbia
  - Vancouver, British Columbia, Canada, V5Z 1M9
    - Rekruttering
    - Vancouver Coastal Health Authority
    - Ledende efterforsker:
      
      Jason Andrade, MD
- Manitoba
  - Winnipeg, Manitoba, Canada, R2H 2A6
    - Rekruttering
    - St. Boniface Hospital Inc.
    - Ledende efterforsker:
      
      Malek Kass, MD
- Ontario
  - Burlington, Ontario, Canada, L7M 1K9
    - Rekruttering
    - Circulate Cardiac & Vascular Centre (CCVC)
    - Ledende efterforsker:
      
      Hisham Dokainish, MD
  - Cambridge, Ontario, Canada, N1R 6V6
    - Rekruttering
    - Cambridge Cardiac Care Inc.
    - Ledende efterforsker:
      
      A. Shekhar Pandey, MD
  - Hamilton, Ontario, Canada, L8N 4A6
    - Rekruttering
    - Research St. Joseph's - Hamilton
    - Ledende efterforsker:
      
      Vikas Tandon, MD
  - Hamilton, Ontario, Canada, L8L 2X2
    - Rekruttering
    - Hamilton Health Sciences Corp
    - Ledende efterforsker:
      
      Guy Amit, MD
  - Kitchener, Ontario, Canada, N2M 5N6
    - Rekruttering
    - Waterloo Wellington Cardiovascular Research Institute (WWCRI)
    - Ledende efterforsker:
      
      Umjeet Jolly, MD
  - London, Ontario, Canada, N6A 2R5
    - Rekruttering
    - Lawson Health Research Institute
    - Ledende efterforsker:
      
      Allan Skanes, MD
  - Newmarket, Ontario, Canada, L2Y 2P9
    - Rekruttering
    - Southlake Regional Health Centre
    - Ledende efterforsker:
      
      Mouhannad Sadek, MD
  - Newmarket, Ontario, Canada, L3Y 2P6
    - Rekruttering
    - Partners in Advanced Cardiac Evaluation (PACE)
    - Ledende efterforsker:
      
      Yaariv Khaykin, MD
  - Ottawa, Ontario, Canada, K1Y 4W7
    - Rekruttering
    - Ottawa Heart Institute Research Corp
    - Ledende efterforsker:
      
      Omar Abdel-Razek, MD
  - St. Catharines, Ontario, Canada, L2S 0A9
    - Rekruttering
    - Niagara Health Systems - St. Catharines
    - Ledende efterforsker:
      
      Nigel Tan, MD
  - St. Catharines, Ontario, Canada, L2S 0A9
    - Trukket tilbage
    - Niagara Health System - Niagara Falls
  - Toronto, Ontario, Canada, M4N 3M5
    - Rekruttering
    - Sunnybrook Health Sciences Center
    - Ledende efterforsker:
      
      Sheldon Singh, MD
  - Toronto, Ontario, Canada, M5G 2C4
    - Rekruttering
    - University Health Network
    - Ledende efterforsker:
      
      Eric Horlick, MD
  - Toronto, Ontario, Canada, M4N 3N1
    - Rekruttering
    - Lawrence Park Cardiology
    - Ledende efterforsker:
      
      Eugene Crystal, MD
  - Toronto, Ontario, Canada, M5B 1W8
    - Rekruttering
    - Unity Health Toronto
    - Ledende efterforsker:
      
      Neil Fam, MD
- Quebec
  - Montreal, Quebec, Canada, H1T 1C8
    - Rekruttering
    - Institut de Cardiologie de Montreal (ICM)
    - Ledende efterforsker:
      
      Reda Ibrahim, MD
  - Montreal, Quebec, Canada, H2X OC1
    - Rekruttering
    - Centre hospitalier de l'Université de Montréal
    - Ledende efterforsker:
      
      Jean-Marc Raymond, MD
  - Québec, Quebec, Canada, G1V 4G5
    - Rekruttering
    - Institut universitaire de cardiologie et de pneumologie de Québec-Université Laval
    - Ledende efterforsker:
      
      Jean Champagne, MD
  - Sherbrooke, Quebec, Canada, J1J 3H5
    - Rekruttering
    - Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre hospitalier universitaire de Sherbrooke (CIUSSS de l'Estrie - CHUS)
    - Ledende efterforsker:
      
      Charles Dussault, MD
- Saskatchewan
  - Regina, Saskatchewan, Canada, S4P 0W5
    - Rekruttering
    - Prairie Valscular Research Inc. (PVRI)
    - Ledende efterforsker:
      
      Payam Dehghani, MD
  - Saskatoon, Saskatchewan, Canada, S7K 0M7
    - Rekruttering
    - Saskatchewan Health Authority
    - Ledende efterforsker:
      
      Stephan Wardell, MD
Danmark
- - Copenhagen, Danmark, 2100
    - Rekruttering
    - Rigshospitalet (RH)
    - Ledende efterforsker:
      
      Ole De Backer, MD
  - Hjørring, Danmark, 9800
    - Rekruttering
    - North Denmark Regional Hospital
    - Ledende efterforsker:
      
      Albert Marni Joensen, MD
  - Odense C, Danmark, 4500
    - Rekruttering
    - Odense Universitets Hospital
    - Ledende efterforsker:
      
      Mikkel Hougaard, MD
- Central Jutland
  - Viborg, Central Jutland, Danmark, 8800
    - Rekruttering
    - Region Hospital Viborg
    - Ledende efterforsker:
      
      Andi Eie Albertsen, MD
- Region Midt
  - Aarhus, Region Midt, Danmark, 8200
    - Rekruttering
    - Aarhus University Hospital (AUH)
    - Ledende efterforsker:
      
      Jens Erik Nielsen-Kudsk, MD
- Region Syddanmark
  - Esbjerg, Region Syddanmark, Danmark, 6700
    - Rekruttering
    - Esbjerg & Grindsted Hospital - University Hospital of Southern Denmark
    - Ledende efterforsker:
      
      Axel Brandes, MD
Det Forenede Kongerige
- - Liverpool, Det Forenede Kongerige, L14 3PE
    - Rekruttering
    - Liverpool Heart and Chest Hospital NHS Foundation Trust
    - Ledende efterforsker:
      
      Dhiraj Gupta, MD
  - Southampton, Det Forenede Kongerige, SO16 6YD
    - Rekruttering
    - University Hospital Southampton NHS Foundation Trust
    - Ledende efterforsker:
      
      John Paisey, MD
- Leicestershire
  - Leicester, Leicestershire, Det Forenede Kongerige, LE1 5WW
    - Rekruttering
    - University Hospitals of Leicester NHS Trust
    - Ledende efterforsker:
      
      Jan Kovac, Prof., MD
- Nottinghamshire
  - Nottingham, Nottinghamshire, Det Forenede Kongerige, NG5 1PB
    - Rekruttering
    - Nottingham University Hospital NHS Trust
    - Ledende efterforsker:
      
      Ashan Gunarathne, MD
- Oxfordshire
  - Oxford, Oxfordshire, Det Forenede Kongerige, OX3 9DU
    - Rekruttering
    - Oxford University Hospitals NHS Foundation Trust
    - Ledende efterforsker:
      
      Tim Betts, MD
- West Midlands
  - Coventry, West Midlands, Det Forenede Kongerige, CV2 2DX
    - Rekruttering
    - University Hospitals Coventry and Warwickshire
    - Ledende efterforsker:
      
      Sandeep Panikker, MD
- West Sussex
  - Worthing, West Sussex, Det Forenede Kongerige, BN11 2DH
    - Rekruttering
    - University Hospitals Sussex NHS Trust
    - Ledende efterforsker:
      
      David Hildick-Smith, MD
Forenede Stater
- Alabama
  - Birmingham, Alabama, Forenede Stater, 35243
    - Trukket tilbage
    - Affinity Hospital dba Grandview Medical Center
- Arkansas
  - Jonesboro, Arkansas, Forenede Stater, 72401
    - Rekruttering
    - Arrhythmia Research Group
    - Ledende efterforsker:
      
      Devi Nair, MD
- California
  - Fountain Valley, California, Forenede Stater, 92708
    - Rekruttering
    - Memorial Health Services
    - Ledende efterforsker:
      
      Nikhil Warrier, MD
  - Loma Linda, California, Forenede Stater, 92354
    - Trukket tilbage
    - Loma Linda University Health
  - Los Angeles, California, Forenede Stater, 90048
    - Rekruttering
    - Cedars-Sinai Medical Center
    - Ledende efterforsker:
      
      Tarun Chakravarty, MD
  - Pasadena, California, Forenede Stater, 91101
    - Rekruttering
    - Southern California Permanente Medical Group
    - Ledende efterforsker:
      
      Bahram Khadivi, MD
  - Sacramento, California, Forenede Stater, 95816
    - Rekruttering
    - Sutter Valley Hospitals dba Sutter Institute for Medical Research
    - Ledende efterforsker:
      
      David Roberts, MD
- Delaware
  - Wilmington, Delaware, Forenede Stater, 19803
    - Rekruttering
    - Christiana Care Health Services, Inc.
    - Ledende efterforsker:
      
      Neil Wimmer, MD
- Florida
  - Atlantis, Florida, Forenede Stater, 33462
    - Trukket tilbage
    - JFK Medical Center Limited Partnership d/b/a HCA Florida JFK Hospital
  - Jacksonville, Florida, Forenede Stater, 32204
    - Trukket tilbage
    - St. Vincent's Health System
  - Largo, Florida, Forenede Stater, 33770
    - Trukket tilbage
    - Largo Medical Center, Inc. d/b/a HCA Florida Largo Medical Center
  - Ocala, Florida, Forenede Stater, 34471
    - Trukket tilbage
    - HCA Florida Ocala Hospital
  - Tampa, Florida, Forenede Stater, 33620
    - Rekruttering
    - The University of South Florida
    - Ledende efterforsker:
      
      Bibhu Mohanty, MD
- Georgia
  - Atlanta, Georgia, Forenede Stater, 30322
    - Rekruttering
    - Emory University
    - Ledende efterforsker:
      
      David De Lurgio, MD
- Idaho
  - Boise, Idaho, Forenede Stater, 83712
    - Rekruttering
    - St Luke's Regional Medical Center, Ltd
    - Ledende efterforsker:
      
      Marcos Daccarett, MD
  - Coeur d'Alene, Idaho, Forenede Stater, 83814
    - Rekruttering
    - Kootenai Health Inc.
    - Ledende efterforsker:
      
      Michele Murphy-Cook, MD
- Illinois
  - Evanston, Illinois, Forenede Stater, 60208
    - Rekruttering
    - Northwestern University
    - Ledende efterforsker:
      
      Albert Lin, MD
  - Rock Island, Illinois, Forenede Stater, 61201
    - Rekruttering
    - Cardiovascular Medicine, PLLC and Unity Point Trinity Rock Island
    - Ledende efterforsker:
      
      Mark Shen, MD
- Indiana
  - Indianapolis, Indiana, Forenede Stater, 46256
    - Rekruttering
    - Community Health Network Inc.
    - Ledende efterforsker:
      
      Krishna Malineni, MD
- Iowa
  - West Des Moines, Iowa, Forenede Stater, 50266
    - Rekruttering
    - MercyOne Iowa Heart Center
    - Ledende efterforsker:
      
      Pitayadet Jumrussirikul, MD
- Kansas
  - Kansas City, Kansas, Forenede Stater, 66160
    - Rekruttering
    - University of Kansas Medical Center Research Institute, Inc.
    - Ledende efterforsker:
      
      Madhu Reddy, MD
- Kentucky
  - Lexington, Kentucky, Forenede Stater, 40503
    - Rekruttering
    - Babtist Health Lexington
    - Ledende efterforsker:
      
      Gery Tomassoni, MD
- Louisiana
  - New Orleans, Louisiana, Forenede Stater, 70121
    - Rekruttering
    - Ochsner Clinic Foundation
    - Ledende efterforsker:
      
      Richard Zweifler, MD
- Maryland
  - Baltimore, Maryland, Forenede Stater, 21201
    - Rekruttering
    - University of Maryland Baltimore
    - Ledende efterforsker:
      
      Seemant Chaturvedi, MD
- Massachusetts
  - Burlington, Massachusetts, Forenede Stater, 01805
    - Rekruttering
    - Lahey Clinic Inc.
    - Ledende efterforsker:
      
      Bruce Hook, MD
- Michigan
  - Ann Arbor, Michigan, Forenede Stater, 48109
    - Rekruttering
    - University of Michigan
    - Ledende efterforsker:
      
      Hakan Oral, MD
  - Detroit, Michigan, Forenede Stater, 48202
    - Rekruttering
    - Henry Ford Health System
    - Ledende efterforsker:
      
      Amir Kaki, MD
    - Ledende efterforsker:
      
      Waddah Maskoun, MD
- Minnesota
  - Rochester, Minnesota, Forenede Stater, 55905
    - Rekruttering
    - Mayo Clinic
    - Ledende efterforsker:
      
      Eugene L. Scharf, MD
- Missouri
  - St Louis, Missouri, Forenede Stater, 63103
    - Rekruttering
    - St. Louis University,
    - Ledende efterforsker:
      
      Div Verma, MD
- New Jersey
  - Hackensack, New Jersey, Forenede Stater, 07601
    - Rekruttering
    - Hackensack University Medical Center
    - Ledende efterforsker:
      
      Taya Glotzer, MD
- New Mexico
  - Albuquerque, New Mexico, Forenede Stater, 87106
    - Rekruttering
    - Presbyterian Healthcare Services d.b.a. Presbyterian Heart Group
    - Ledende efterforsker:
      
      Sharif Halim, MD
- New York
  - Manhasset, New York, Forenede Stater, 11030
    - Trukket tilbage
    - The Feinstein Institutes for Medical Research
  - New York, New York, Forenede Stater, 10065
    - Rekruttering
    - Cornell University for and on behalf of its Joan & Sanford I. Weill Medical College and The New York Presbyterian Hospital
    - Ledende efterforsker:
      
      Christopher Liu, MD
  - New York, New York, Forenede Stater, 10065
    - Trukket tilbage
    - NYU Grossman School of Medicine
- North Carolina
  - Asheville, North Carolina, Forenede Stater, 28801
    - Rekruttering
    - Mission Hospital HCA
    - Ledende efterforsker:
      
      John Rhyner, MD
- Ohio
  - Canton, Ohio, Forenede Stater, 44710
    - Rekruttering
    - Aultman Hospital
    - Ledende efterforsker:
      
      Firas Hamdan, MD
  - Cincinnati, Ohio, Forenede Stater, 45221
    - Rekruttering
    - University of Cincinnati
    - Ledende efterforsker:
      
      Srinivas Rajsheker, MD
  - Cincinnati, Ohio, Forenede Stater, 45202
    - Rekruttering
    - TriHealth Inc.
    - Ledende efterforsker:
      
      Gaurang Gandhi, MD
  - Cleveland, Ohio, Forenede Stater, 44195
    - Rekruttering
    - Cleveland Clinic
    - Ledende efterforsker:
      
      Oussama Wazni, MD
- Oklahoma
  - Tulsa, Oklahoma, Forenede Stater, 74136
    - Rekruttering
    - Saint Francis Hospital
    - Ledende efterforsker:
      
      Tom Hu, MD
- Pennsylvania
  - Hershey, Pennsylvania, Forenede Stater, 17033
    - Rekruttering
    - The Pennsylvania State University and The Milton S. Hershey Medical Center
    - Ledende efterforsker:
      
      Soraya Samii, MD
  - Philadelphia, Pennsylvania, Forenede Stater, 19104
    - Rekruttering
    - The Trustees of the University of Pennsylvania
    - Ledende efterforsker:
      
      Steven Messe, MD
  - Pittsburgh, Pennsylvania, Forenede Stater, 15213
    - Rekruttering
    - University of Pittsburgh Medical Center (UPMC) Presbyterian Heart and Vascular Institute
    - Ledende efterforsker:
      
      Sandeep Jain, MD
- Rhode Island
  - Providence, Rhode Island, Forenede Stater, 02903
    - Rekruttering
    - Rhode Island Hospital
    - Ledende efterforsker:
      
      Ana-Lucia Garcia-Guarniz, MD
- Tennessee
  - Brentwood, Tennessee, Forenede Stater, 37027
    - Trukket tilbage
    - Glanecare, Inc. d/b/a HCA Florida Brandon Hospital
  - Memphis, Tennessee, Forenede Stater, 38163
    - Rekruttering
    - The University of Tennessee
    - Ledende efterforsker:
      
      Balaji Krishnaiah, MD
- Texas
  - Austin, Texas, Forenede Stater, 78705
    - Trukket tilbage
    - Texas Cardiac Arrhythmia Research Foundation
  - Dallas, Texas, Forenede Stater, 75204
    - Rekruttering
    - Baylor Research Institute
    - Ledende efterforsker:
      
      Praveen Rao, MD
  - The Woodlands, Texas, Forenede Stater, 77380
    - Trukket tilbage
    - Heart Rhythm Associates
  - Tyler, Texas, Forenede Stater, 75701-2263
    - Rekruttering
    - CHRISTUS Northeast Texas Health System
    - Ledende efterforsker:
      
      Stanislav Weiner, MD
- Virginia
  - Charlottesville, Virginia, Forenede Stater, 22903
    - Rekruttering
    - The Rector and Visitors of the University of Virginia
    - Ledende efterforsker:
      
      Rohit Malhotra, MD
- Washington
  - Tacoma, Washington, Forenede Stater, 98405
    - Rekruttering
    - CommonSpirit Health Research Institute
    - Ledende efterforsker:
      
      Nasir Shariff, MD
- Wisconsin
  - Milwaukee, Wisconsin, Forenede Stater, 53226
    - Rekruttering
    - The Medical College of Wisconsin
    - Ledende efterforsker:
      
      James Oujiri, MD
Frankrig
- - Lyon, Frankrig, 69677
    - Rekruttering
    - Hospices Civils de Lyon
    - Ledende efterforsker:
      
      Brahim Harbaoui, Prof., MD
  - Paris, Frankrig, 75013
    - Rekruttering
    - Hôpital Pitie Salpétrière
    - Ledende efterforsker:
      
      Johanne Silvain, Prof., MD
  - Paris, Frankrig, 75018
    - Rekruttering
    - Hôpital Bichat
    - Ledende efterforsker:
      
      Gregory Ducrocq, Prof., MD
  - Paris, Frankrig, 75908
    - Rekruttering
    - European Georges Pompidou Hospital
    - Ledende efterforsker:
      
      Eloi Marijon, MD
  - Paris, Frankrig, 75014
    - Rekruttering
    - Institut Médico-chirurgical Montsouris
    - Ledende efterforsker:
      
      Alaa Masri, MD
  - Paris, Frankrig, 75012
    - Rekruttering
    - The Fondation de l'AP-HP
    - Ledende efterforsker:
      
      Emmanuel Teiger, Prof., MD
- Essonne
  - Massy, Essonne, Frankrig, 91300
    - Rekruttering
    - Hospital Prive Jacques Cartier
    - Ledende efterforsker:
      
      Phillipe Garot, MD
- Indre-et-Loire
  - Tours, Indre-et-Loire, Frankrig, 37044
    - Rekruttering
    - Centre Hospitalier Régional Universitaire de Tours
    - Ledende efterforsker:
      
      Jean Michel Clerc, MD
- Isère
  - La Tronche, Isère, Frankrig, 38700
    - Rekruttering
    - Centre Hospitalier Universitaire Grenoble-Alps
    - Ledende efterforsker:
      
      Pascal Defaye, Prof., MD
- Moselle
  - Ars-Laquenexy, Moselle, Frankrig
    - Rekruttering
    - CHR Metz-Thionville / Hôpital de MERCY
    - Ledende efterforsker:
      
      Marwan Yassine, MD
- Occitanie
  - Toulouse, Occitanie, Frankrig, 31076
    - Rekruttering
    - Clinique Pasteur
    - Ledende efterforsker:
      
      Serge Boveda, MD
  - Toulouse, Occitanie, Frankrig, 31076
    - Rekruttering
    - SCP des Médecins Cardiologues
    - Ledende efterforsker:
      
      Bruno Farah, MD
  - Toulouse, Occitanie, Frankrig, 31059
    - Rekruttering
    - Centre Hospitalier Universitaire de Toulouse
    - Ledende efterforsker:
      
      Meyer Elbaz, Prof., MD
- Pays de la Loire Region
  - Saint-Étienne-de-Montluc, Pays de la Loire Region, Frankrig, 42055
    - Rekruttering
    - CHU Saint Etienne
    - Ledende efterforsker:
      
      Antoine Da Costa, Prof., MD
- Rhône
  - Caluire-et-Cuire, Rhône, Frankrig, 69300
    - Rekruttering
    - Infirmerie Protestante de Lyon
    - Ledende efterforsker:
      
      Cyril Durand, MD
  - Marseille, Rhône, Frankrig, 13005
    - Rekruttering
    - L'Assistance Publique-Hôpitaux de Marseille
    - Ledende efterforsker:
      
      Thomas Cuisset, MD
  - Marseille, Rhône, Frankrig, 13009
    - Rekruttering
    - Hôpital Privé Clairval
    - Ledende efterforsker:
      
      Alexis Mechulan, MD
- Seine-Saint-Denis
  - Saint-Denis, Seine-Saint-Denis, Frankrig, 93200
    - Rekruttering
    - Centre Cardiologique due Nord
    - Ledende efterforsker:
      
      Antoine Lepillier, MD
Holland
- North Brabant
  - Eindhoven, North Brabant, Holland, 5623EJ
    - Rekruttering
    - Stichting Catharina Ziekenhuis
    - Ledende efterforsker:
      
      Pepijn van der Voort, MD
- Utrecht
  - Nieuwegein, Utrecht, Holland, 3435CM
    - Rekruttering
    - St. Antonius Hospital
    - Ledende efterforsker:
      
      Lucas Boersma, Prof., MD
Italien
- - Brescia, Italien, 25124
    - Rekruttering
    - Fondazione Poliambulanza Istituto Ospedaliero
    - Ledende efterforsker:
      
      Diego Maffeo, MD
  - Sassari, Italien, 07100
    - Rekruttering
    - Azienda Ospedaliero Universitaria Sassari
    - Ledende efterforsker:
      
      Gavino Casu, Prof., MD
Polen
- - Ustroń, Polen, 43-450
    - Rekruttering
    - American Heart of Poland SA
    - Ledende efterforsker:
      
      Krzysztof Milewski, MD
- Masovian Voivodeship
  - Warsaw, Masovian Voivodeship, Polen, 04-628
    - Rekruttering
    - Narodowy Instytut Kardiologii Stefana kardynała Wyszyńskiego
    - Ledende efterforsker:
      
      Jerzy Pregowski, MD
Schweiz
- Canton of Basel-City
  - Basel, Canton of Basel-City, Schweiz, 4031
    - Rekruttering
    - Universitätsspital Basel
    - Ledende efterforsker:
      
      Christian Sticherling, Prof., MD
Spanien
- - Alicante, Spanien, 03010
    - Rekruttering
    - University General Hospital Dr. Balmis
    - Ledende efterforsker:
      
      Juan Miguel Ruiz Nodar, MD
  - Barcelona, Spanien, 08035
    - Rekruttering
    - Hospital Universitari Vall d'Hebron
    - Ledende efterforsker:
      
      Jaume Francisco Pascual, MD
  - Huelva, Spanien, 21005
    - Rekruttering
    - Hospital Universitario Juan Ramón Jiménez
    - Ledende efterforsker:
      
      Antonio Enrique Gómez Menchero, MD
  - León, Spanien, 24071
    - Rekruttering
    - Complejo Asistencial Universitario de León
    - Ledende efterforsker:
      
      Armando Perez de Prado, MD
  - Madrid, Spanien, 28003
    - Rekruttering
    - Universitario La Luz - Grupo Quirónsalud
    - Ledende efterforsker:
      
      Jorge Palazuelos, MD
  - Valladolid, Spanien, 47003
    - Rekruttering
    - Hospital Clínico Universitario de Valladolid
    - Ledende efterforsker:
      
      Ignacio Amat Santos, MD
- Pontevedra
  - Vigo, Pontevedra, Spanien, 36312
    - Rekruttering
    - Hospital Álvaro Cunqueiro
    - Ledende efterforsker:
      
      Rodrigo Estevez Loureiro, MD
Tyskland
- - Berlin, Tyskland, 12203
    - Rekruttering
    - Charité - Universitätsmedizin Berlin
    - Ledende efterforsker:
      
      Carsten Skurk, MD
  - Berlin, Tyskland, 10117
    - Rekruttering
    - Charité Universitätsmedizin Berlin
    - Ledende efterforsker:
      
      Leif-Hendrik Boldt, MD
  - Hamburg, Tyskland, 20246
    - Rekruttering
    - Universitätsklinikum Hamburg-Eppendorf (UKE)
    - Ledende efterforsker:
      
      Andreas Metzner, Prof., MD
  - Hamburg, Tyskland, 20099
    - Rekruttering
    - Asklepios Kliniken Hamburg GmbH
    - Ledende efterforsker:
      
      Martin Bergmann, MD
    - Ledende efterforsker:
      
      Arian Sultan, MD
  - Heidelberg, Tyskland, 69120
    - Rekruttering
    - Universitätsklinikum Heidelberg
    - Ledende efterforsker:
      
      Farbod Sedaghat-Hamedani, MD
- Baden-Wurttemberg
  - Karlsruhe, Baden-Wurttemberg, Tyskland, 76133
    - Rekruttering
    - Städtisches Klinikum Karsruhe gGmbH
    - Ledende efterforsker:
      
      Armin Luik, Prof., MD
- Hesse
  - Darmstadt, Hesse, Tyskland, 64287
    - Rekruttering
    - Kardiovaskulaeres Zentrum Darmstadt
    - Ledende efterforsker:
      
      Jörg Honold, MD
  - Frankfurt am Main, Hesse, Tyskland, 60389
    - Rekruttering
    - CVC Rhein-Main GmbH
    - Ledende efterforsker:
      
      Horst Sievert, MD
  - Frankfurt am Main, Hesse, Tyskland, 60431
    - Rekruttering
    - MVZ CCB Frankfurt und Main-Taunus GbR
    - Ledende efterforsker:
      
      Boris Schmidt, MD
  - Frankfurt am Main, Hesse, Tyskland, 60590
    - Rekruttering
    - Johann Wolfgang Goethe Universität Franfurt - Universitätsklinikum Franfurt
    - Ledende efterforsker:
      
      Reza Wakili, MD
- Mecklenburg-Vorpommern
  - Rostock, Mecklenburg-Vorpommern, Tyskland, D-18057
    - Rekruttering
    - Universitätsmedizin Rostock
    - Ledende efterforsker:
      
      Hueseyin Ince, Prof., MD
- North Rhine-Westphalia
  - Bad Oeynhausen, North Rhine-Westphalia, Tyskland, 32545
    - Rekruttering
    - Krankenhausbetriebsgesellschaft Bad Oeynhausen mbH
    - Ledende efterforsker:
      
      Werner Scholtz, MD
  - Cologne, North Rhine-Westphalia, Tyskland, 50937
    - Rekruttering
    - Universitätsklinikum Köln (AöR)
    - Ledende efterforsker:
      
      Daniel Steven, Prof., MD
- Rhineland-Palatinate
  - Kaiserslautern, Rhineland-Palatinate, Tyskland, 67665
    - Rekruttering
    - Westpfalz-Klinikum GmbH
    - Ledende efterforsker:
      
      Burghard Schumacher, MD
- Saxony
  - Leipzig, Saxony, Tyskland, 04289
    - Rekruttering
    - Herzzentrum Leipzig GmbH
    - Ledende efterforsker:
      
      Marcus Sandri, MD
  - Zwickau, Saxony, Tyskland, 08060
    - Rekruttering
    - Heinrich-Braun-Klinikum gemeinnützige GmbH
    - Ledende efterforsker:
      
      Holger H. Sigusch, MD
- Schleswig-Holstein
  - Lübeck, Schleswig-Holstein, Tyskland, 23538
    - Rekruttering
    - Universitätsklinikum Schleswig - Holstein
    - Ledende efterforsker:
      
      Ingo Eitel, MD
- Thuringia
  - Erfurt, Thuringia, Tyskland, 99097
    - Rekruttering
    - Katholisches Krankenhaus "St. Johann Nepomuk"
    - Ledende efterforsker:
      
      Henning Ebelt, MD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

(a) Persistent or permanent atrial fibrillation OR (b) Paroxysmal atrial fibrillation in participants with a history of ischemic stroke or systemic embolism
Increased risk of stroke, defined as a CHA2DS2-VASc stroke risk score of ≥ 4. [Note: the acronym CHA2DS2-VASc stands for congestive heart failure, hypertension, age ≥75 (doubled), diabetes, stroke (doubled), vascular disease, age 65 to 74 and sex category (female).]
Treatment with oral anticoagulants (Vitamin K agonist or factor Xa inhibitor) for at least 90 days prior to enrollment, AND no documented plan to discontinue treatment with oral anticoagulants for the expected duration of the trial.

Exclusion Criteria:

Age < 18 years
Current left atrial appendage thrombus
Prior left atrial appendage occlusion or removal (surgical or percutaneous)
Prior percutaneous atrial septal defect or patent foramen ovale closure
Prior atrial fibrillation ablation unless evidence of recurrent qualifying atrial fibrillation present at least 30 days following ablation
Planned atrial fibrillation ablation within 90 days of enrollment
Individuals being treated with direct thrombin inhibitors
Women of childbearing potential unless they agree to employ effective birth control methods throughout the study
Anticipated life-expectancy of < 2 years
Patient unable or willing to give informed consent

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Primært formål: Behandling
Tildeling: Randomiseret
Interventionel model: Parallel tildeling
Maskning: Enkelt

Antal våben

Våben og indgreb

Deltagergruppe / Arm	Intervention / Behandling
Eksperimentel: WATCHMAN device Participants will undergo endovascular left atrial appendage occlusion with the WATCHMAN device	Enhed: WATCHMAN device Participants will undergo endovascular left atrial appendage occlusion with the WATCHMAN device
Ingen indgriben: Standard Care Participants will receive local, standard medical care

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Ischemic stroke or systemic embolism Tidsramme: The study duration is event-driven. The primary analysis will be performed through study completion, once 265 primary efficacy endpoint events have occurred (an estimated average follow-up of 4 years).	The primary efficacy variable is the time from randomization to first occurrence of any of the components of the composite outcome (adjudicated) over the duration of follow-up, including: Ischemic stroke (Strokes of undetermined etiology will be treated as ischemic stroke) Systemic embolism	The study duration is event-driven. The primary analysis will be performed through study completion, once 265 primary efficacy endpoint events have occurred (an estimated average follow-up of 4 years).

Sekundære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
All-cause stroke or systemic embolism Tidsramme: Will be evaluated once primary outcome meets statistical significance. The primary analysis will be performed through study completion, once 265 primary efficacy endpoint events have occurred (an estimated average follow-up of 4 years).	Secondary efficacy outcomes will be evaluated in a hierarchical fashion only when the primary outcome meets statistical significance in the specified order: Time from randomization to first occurrence of all-cause stroke or systemic embolism	Will be evaluated once primary outcome meets statistical significance. The primary analysis will be performed through study completion, once 265 primary efficacy endpoint events have occurred (an estimated average follow-up of 4 years).
All-cause stroke, systemic embolism, or transient ischemic attack (TIA) Tidsramme: Will be evaluated once primary outcome meets statistical significance. The primary analysis will be performed through study completion, once 265 primary efficacy endpoint events have occurred (an estimated average follow-up of 4 years).	Time from randomization to first occurrence of all-cause stroke, systemic embolism or transient ischemic attack (TIA)	Will be evaluated once primary outcome meets statistical significance. The primary analysis will be performed through study completion, once 265 primary efficacy endpoint events have occurred (an estimated average follow-up of 4 years).
Montreal Cognitive Assessment (MoCA) Score Tidsramme: Will be evaluated once primary outcome meets statistical significance. The primary analysis will be performed through study completion, once 265 primary efficacy endpoint events have occurred (an estimated average follow-up of 4 years).	Proportion of participants with a decrease of two or more points on the MoCA score at either year 2 or end of study	Will be evaluated once primary outcome meets statistical significance. The primary analysis will be performed through study completion, once 265 primary efficacy endpoint events have occurred (an estimated average follow-up of 4 years).
New disabling ischemic strokes Tidsramme: Will be evaluated once primary outcome meets statistical significance. The primary analysis will be performed through study completion, once 265 primary efficacy endpoint events have occurred (an estimated average follow-up of 4 years).	Time from randomization to first occurrence of disabling ischemic strokes with modified Rankin Score (mRS) >2, measured at 90 days post-stroke	Will be evaluated once primary outcome meets statistical significance. The primary analysis will be performed through study completion, once 265 primary efficacy endpoint events have occurred (an estimated average follow-up of 4 years).
Cardiovascular mortality Tidsramme: Will be evaluated once primary outcome meets statistical significance. The primary analysis will be performed through study completion, once 265 primary efficacy endpoint events have occurred (an estimated average follow-up of 4 years).	Time from randomization to cardiovascular mortality	Will be evaluated once primary outcome meets statistical significance. The primary analysis will be performed through study completion, once 265 primary efficacy endpoint events have occurred (an estimated average follow-up of 4 years).
All-cause mortality Tidsramme: Will be evaluated once primary outcome meets statistical significance. The primary analysis will be performed through study completion, once 265 primary efficacy endpoint events have occurred (an estimated average follow-up of 4 years).	Time from randomization to all-cause mortality	Will be evaluated once primary outcome meets statistical significance. The primary analysis will be performed through study completion, once 265 primary efficacy endpoint events have occurred (an estimated average follow-up of 4 years).

Andre resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Non-procedural Major Bleeding Tidsramme: Will be evaluated once primary outcome meets statistical significance. The primary analysis will be performed through study completion, once 265 primary efficacy endpoint events have occurred (an estimated average follow-up of 4 years).	Proportion of participants with non-procedural Major Bleeding (International Society on Thrombosis and Haemostasis (ISTH) definition; excluding WATCHMAN-related bleeding within 14 days of implant)	Will be evaluated once primary outcome meets statistical significance. The primary analysis will be performed through study completion, once 265 primary efficacy endpoint events have occurred (an estimated average follow-up of 4 years).
Hospitalization for any cause Tidsramme: Will be evaluated once primary outcome meets statistical significance. The primary analysis will be performed through study completion, once 265 primary efficacy endpoint events have occurred (an estimated average follow-up of 4 years).	Time from randomization to first occurrence of hospitalization for any cause	Will be evaluated once primary outcome meets statistical significance. The primary analysis will be performed through study completion, once 265 primary efficacy endpoint events have occurred (an estimated average follow-up of 4 years).
Heart failure hospitalization or emergency department/clinic visit for intensification of heart failure related therapy Tidsramme: Will be evaluated once primary outcome meets statistical significance. The primary analysis will be performed through study completion, once 265 primary efficacy endpoint events have occurred (an estimated average follow-up of 4 years).	Time from randomization to first occurrence of heart failure hospitalization or emergency department/clinic visit for intensification of heart failure related therapy	Will be evaluated once primary outcome meets statistical significance. The primary analysis will be performed through study completion, once 265 primary efficacy endpoint events have occurred (an estimated average follow-up of 4 years).
Myocardial Infarction Tidsramme: Will be evaluated once primary outcome meets statistical significance. The primary analysis will be performed through study completion, once 265 primary efficacy endpoint events have occurred (an estimated average follow-up of 4 years).	Time from randomization to first occurrence of Myocardial Infarction (4th Universal definition)	Will be evaluated once primary outcome meets statistical significance. The primary analysis will be performed through study completion, once 265 primary efficacy endpoint events have occurred (an estimated average follow-up of 4 years).
Device and procedural-related outcomes: Device-related thrombus Tidsramme: Will be evaluated once primary outcome meets statistical significance. The primary analysis will be performed through study completion, once 265 primary efficacy endpoint events have occurred (an estimated average follow-up of 4 years).	Proportion of participants with device-related thrombus (thrombus formed on the surface of the WATCHMAN device)	Will be evaluated once primary outcome meets statistical significance. The primary analysis will be performed through study completion, once 265 primary efficacy endpoint events have occurred (an estimated average follow-up of 4 years).
Device and procedural-related outcomes: Incomplete left atrial appendage (LAA) closure Tidsramme: Will be evaluated once primary outcome meets statistical significance. The primary analysis will be performed through study completion, once 265 primary efficacy endpoint events have occurred (an estimated average follow-up of 4 years).	Proportion of participants with incomplete LAA closure	Will be evaluated once primary outcome meets statistical significance. The primary analysis will be performed through study completion, once 265 primary efficacy endpoint events have occurred (an estimated average follow-up of 4 years).
Device and procedural-related outcomes: Peri-procedural major bleeding Tidsramme: Will be evaluated once primary outcome meets statistical significance. The primary analysis will be performed through study completion, once 265 primary efficacy endpoint events have occurred (an estimated average follow-up of 4 years).	Proportion of participants with peri-procedural major bleeding (ISTH definition; within 14 days following the procedure)	Will be evaluated once primary outcome meets statistical significance. The primary analysis will be performed through study completion, once 265 primary efficacy endpoint events have occurred (an estimated average follow-up of 4 years).

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Hamilton Health Sciences Corporation

Samarbejdspartnere

McMaster University

Boston Scientific Corporation

Population Health Research Institute

Efterforskere

Ledende efterforsker: Jeff Healey, Hamilton Health Sciences Corporation

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Grifoni E, Pagni B, Sansone T, Baldini M, Bertini E, Giannoni S, Di Donato I, Sivieri I, Iandoli G, Mannini M, Giglio E, Vescera V, Brai E, Signorini I, Cosentino E, Micheletti I, Cioni E, Pelagalli G, Dei A, Giordano A, Dainelli F, Romagnoli M, Mattaliano C, Schipani E, Murgida GS, Di Martino S, Francolini V, Masotti L. Clinical Features, Management, and Recurrence of Acute Ischemic Stroke Occurring in Patients on Oral Anticoagulant Treatment for Nonvalvular Atrial Fibrillation: A Real-World Retrospective Study. Neurologist. 2024 Nov 1;29(6):329-338. doi: 10.1097/NRL.0000000000000579.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

30. november 2023

Primær færdiggørelse (Anslået)

1. september 2029

Studieafslutning (Anslået)

1. december 2029

Datoer for studieregistrering

Først indsendt

5. juli 2023

Først indsendt, der opfyldte QC-kriterier

18. juli 2023

Først opslået (Faktiske)

27. juli 2023

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. september 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

LAAOS-4

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Den fjerde venstre atrielle appendage okklusionsundersøgelse (LAAOS-4)